Plain English Summary
Background and study aims
Stroke is the second leading cause of death and disability among adults worldwide and the prevalence is still increasing. Constipation is one of the most common complications after stroke that severely influences patients’ quality of life and their rehabilitation. Studies indicate that about 30% to 60% of stroke patients have suffered from constipation after stroke. Although treatments for constipation are varied, many of them are difficult to tolerate or are rejected because of adverse events, or have not been proven to be effective. Acupuncture may be effective for constipation but studies focusing on acupuncture for constipation after stroke are rare. The aim of this study is to compare the effectiveness of acupuncture, mosapride citrate tablet and routine health care in patients with constipation after ischemic stroke.
Who can participate?
Patients aged between 30 and 75 diagnosed with ischemic stroke with symptoms of constipation.
What does the study involve?
Participants will be randomly allocated into one of three groups. The first group will be treated with acupuncture. They will receive 16 treatment sessions over 4 weeks. Each session will last for 30 minutes. The second group will take a mosapride citrate tablet three times a day for 4 weeks. The third group will receive routine treatment and healthcare for ischemic stroke.
What are the possible benefits and risks of participating?
The participants' symptoms of constipation may be improved by participating in the study. The results of the study will help clinicians select more effective treatments for constipation. Participants may feel soreness, numbness, distension or heaviness around the acupuncture points. If the following events occur, they will be regarded as adverse events and the researchers will treat the participants with relevant conventional therapy, or even hospitalize them. The adverse events include local hematoma (a solid swelling of clotted blood), breaking of needle, retained needle after treatment, fainting, unbearable prickling, severe pain or discomfort persisting more than 1 hour after acupuncture, local infection and abscess, diarrhea, abdominal pain, and hives.
Where is the study run from?
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China).
When is the study starting and how long is it expected to run for?
From December 2015 to July 2018.
Who is funding the study?
Beijing Municipal Science and Technology Commission, Beijing Municipal Administration of Hospitals, Ministry of Science and Technology of the People's Republic of China and State Administration of Traditional Chinese Medicine of the People's Republic of China.
Who is the main contact?
Dr Tao Zhang
Trial website
Contact information
Type
Scientific
Primary contact
Dr Tao Zhang
ORCID ID
http://orcid.org/0000-0002-8349-9091
Contact details
Beijing Hospital of Traditional Chinese Medicine
No. 23 Meishuguanhoujie
Dongcheng District
Beijing
100010
China
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of acupuncture versus mosapride citrate tablet versus routine health care in improving spontaneous bowel movements, stool consistency and straining during defecation in patients with constipation after ischemic stroke: a single-centre randomised controlled trial
Acronym
Study hypothesis
Acupuncture is effective for constipation after ischemic stroke. The effect of acupuncture is at least equivalent to mosapride citrate table but is better than conventional health care.
Ethics approval
Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 09/07/2015, ref: 2015BL-041-01
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Constipation after ischemic stroke
Intervention
1. Acupuncture group: acupuncture point selection: CV13 (Shangwan), CV12 (Zhongwan), CV10 (Xiawan), bilateral ST25 (Tianshu), CV6 (Qihai), bilateral PC6 (Neiguan) and bilateral ST36 (Zusanli). Each session will last for 30 minutes. Every participant will be treated once a day and will receive 16 treatment sessions in total during 4 continuous weeks. Treatment will be conducted 5 times per week in the first 2 weeks and 3 times per week in the last 2 weeks.
2. Medicine group: mosapride citrate tablet will be taken orally at the dose of 5 mg, three times a day for 4 weeks continuously.
3. Control group: participants of control group only receive routine treatment and healthcare for ischemic stroke. For participants who have had no bowel movements over 4 or more consecutive days, a cathartic will be used as an emergency drug.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
The change of mean weekly complete spontaneous bowel movements (CSBMs) from baseline; measured at the 4th and the 8th week after randomisation
Secondary outcome measures
1. The change of mean weekly spontaneous bowel movements (SBMs) from baseline, measured at the 4th and the 8th week after randomisation
2. The change of mean scores of stool consistency from baseline, measured at the 4th and the 8th week after randomisation
3. The change of mean scores of straining during defecation from baseline, measured at the 4th and the 8th week after randomisation
4. The change of weekly frequency of using laxatives from baseline, measured at the 4th and the 8th week after randomisation
Overall trial start date
01/12/2015
Overall trial end date
31/07/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosed with ischemic stroke according to the diagnostic criteria specified by the World Health Organization (WHO)
2. With symptoms of constipation according to the Rome III functional constipation criteria
3. 2 weeks to 6 months after stroke onset
4. Aged between 30 and 75 years old, either gender
5. The Glasgow Coma Scale (GCS) score ≥ 7 and the National Institute of Health Stroke Scale (NIHSS) ≤ 21, which indicates that participants are conscious and without dysfunctions in comprehension
6. With no previous medical history of constipation before stroke onset and the symptoms of constipation present at least 2 weeks continuously after stroke
7. No use of gastrointestinal drugs 1 week before randomisation (except for emergency drugs)
8. No acupuncture treatment for constipation in the previous 2 weeks
9. Volunteered to join the clinical trial and provided a signed informed consent form
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120 participants in total and 40 participants in every group.
Participant exclusion criteria
1. Irritable bowel syndrome (IBS) and constipation secondary to organic diseases (for example, endocrine, metabolic or postoperative diseases) or drugs
2. Participants with abdominal aneurysm, hepatosplenomegaly, serious cardiovascular, liver, kidney or psychiatric disease, or severe dystrophy who cannot cooperate to be examined or treated
3. Pregnant women or women in lactation
4. Blood coagulation disorders, or administration of anticoagulant agents such as warfarin and heparin (participants treated with antiplatelet treatment such as asprin or clopidogrel as secondary prevention of cerebral infarction are eligible)
Recruitment start date
01/12/2015
Recruitment end date
28/02/2018
Locations
Countries of recruitment
China
Trial participating centre
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
No.23 Meishuguanhoujie
Dongcheng District
Beijing
100010
China
Sponsor information
Organisation
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Sponsor details
No. 23 Meishuguanhoujie
Beijing
100010
China
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Beijing Municipal Science and Technology Commission
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Beijing Municipal Administration of Hospitals
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministry of Science and Technology of the People's Republic of China
Alternative name(s)
Chinese Ministry of Science and Technology, MOST
Funding Body Type
government organisation
Funding Body Subtype
federal
Location
China
Funder name
State Administration of Traditional Chinese Medicine of the People's Republic of China
Alternative name(s)
State Administration of Traditional Chinese Medicine, State Administration of TCM, SATCM
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
China
Results and Publications
Publication and dissemination plan
The result of this study will be disseminated via peer-reviewed publications and conference presentations.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30134942